What is BS EN 60601-2-17 - Brachytherapy afterloading equipment about?
BS EN 60601-2-17 is a standard that covers brachytherapy afterloading equipment, ensuring operational safety and stability in brachytherapy applications.
BS EN 60601-2-17 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT, hereafter referred to as ME EQUIPMENT.
BS EN 60601-2-17 applies to automatically-controlled BRACHYTHERAPY AFTERLOADING ME EQUIPMENT used for treatment or alleviation of disease.
BS EN 60601-2-17 specifies requirements for automatically-controlled AFTERLOADING ME EQUIPMENT:
- Which contains and uses only beta, gamma, or NEUTRON-emitting SEALED RADIOACTIVE SOURCES, or BRACHYTHERAPY X-RAY SOURCES designed and constructed for use with automatically-controlled AFTERLOADING ME EQUIPMENT
- Which automatically drives the RADIATION SOURCE(S) from a STORAGE CONTAINER or, in the case of BRACHYTHERAPY X-RAY SOURCES, a reference location outside the PATIENT, to a treatment position inside the SOURCE APPLICATOR(S) and returns the RADIATION SOURCE(S) to the STORAGE CONTAINER or the BRACHYTHERAPY X-RAY SOURCE(S) to the reference location
- Which is designed for connection to a PATIENT
- With which movements of the RADIATION SOURCE(S) are carried out automatically by the ME EQUIPMENT according to a prescribed programme using a powered mechanism whose changes are controlled by the CONTROLLING TIMER(S) and TIMING DEVICES that are either PROGRAMMABLE ELECTRONIC SUB-SYSTEMS (PESS) (computer or microprocessors) or non-programmable systems
BS EN 60601-2-17 specifies requirements for ME EQUIPMENT intended to be:
- For NORMAL USE, operated under the authority of appropriately licensed or QUALIFIED PERSONS by OPERATORS having the required skills for a particular medical application, for particular specified clinical purposes
- Maintained in accordance with the recommendations given in the INSTRUCTIONS FOR USE
- Subject to regular quality assurance performance and calibration checks by a QUALIFIED PERSON
Note 1: HAZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within the scope of BS EN 60601-2-17 are not covered by specific requirements in BS EN 60601-2-17 except in 7.2.13 and 8.4.1.
Note 2: BS EN 60601-2-17 does not specify requirements for SEALED RADIOACTIVE SOURCES.
Who is BS EN 60601-2-17 - Brachytherapy afterloading equipment for?
BS EN 60601-2-17 on brachytherapy afterloading equipment applies to:
- Manufacturers of brachytherapy afterloading equipment
- Dealers and importers of brachytherapy afterloading equipment
- Testing houses and labs for brachytherapy afterloading equipment
- Safety assurance services
Why should you use BS EN 60601-2-17 - Brachytherapy afterloading equipment?
The delivery of RADIOTHERAPY over short distances is called BRACHYTHERAPY. BRACHYTHERAPY is delivered by positioning RADIATION SOURCES within or adjacent to the tissue to be treated. AFTERLOADING generally refers to the technique of placing an applicator into or adjacent to the tissue to be treated and introducing one or more RADIATION SOURCE(S) only after the applicator position has been confirmed.
BS EN 60601-2-17 provides users guidance on the requirements based on assumptions that:
- A TREATMENT PLAN is available that prescribes appropriate values of the TREATMENT PARAMETERS
- The SOURCE STRENGTH or the REFERENCE AIR-KERMA RATE of the RADIATION SOURCE used by the ME EQUIPMENT is known
BS EN 60601-2-17 provides users guidance on the requirements intended to ensure that the prescribed values of the TREATMENT PARAMETERS can be achieved by the ME EQUIPMENT, that:
- The selected RADIATION SOURCE(S) is (are) positioned or moved within the SOURCE APPLICATOR in the selected configuration relative to the SOURCE APPLICATOR
- IRRADIATION is performed by the selected RADIATION SOURCE configuration for the selected duration
- IRRADIATION is performed by the ME EQUIPMENT without causing unnecessary RISK to the OPERATOR or other persons in the immediate surroundings
BS EN 60601-2-17 provides users guidance on protection against different hazards, including electrical hazards, mechanical hazards, radiation hazards and EMC compatibility, ensuring the safety and protection in brachytherapy applications.
With obedience and compliance to BS EN 60601-2-17, users can develop and assess brachytherapy afterloading equipment, enabling risk reduction and prevention of hazards to ensure the safety of operators and equipment in brachytherapy applications.
What’s changed since the last update?
BS EN 60601-2-17:2015 supersedes BS EN 60601-2-17:2004, which is now withdrawn.